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Recruiting

Population:
Preterm Infant Pulmonary Hypertension
Start Date:
August 31, 2017
End Date:
December 2021
Phase:
Not Applicable
Institution:
Mount Sinai Hospital
Study Summary
  • The primary objective of this study is to develop new, sensitive, quantitative echocardiographic diagnostic criteria which will allow for the identification of extreme preterm neonates suffering from significantly high pressure in their pulmonary blood vessels, early in postnatal course, when the disease is likely to be most amenable to preventative/curative treatment.
Population:
Patients coming for cardiac catheterization and healthy controls coming for urology surgery
Start Date:
June 20, 2018
End Date:
December 1, 2021
Phase:
Observational
Institution:
The Hospital for Sick Children
Study Summary
  • To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.

     
Population:
PAH
Start Date:
August 22, 2019
End Date:
August 1, 2021
Phase:
I
Institution:
Steeve Provencher
Study Summary
  • The main objective of this proposal is to extend the investigator's preclinical findings on the role of epigenetics and DNA damage and Bromodomain-Containing Protein 4 (BRD4) inhibition as a therapy for a devastating disease, pulmonary arterial hypertension (PAH).
     
Population:
CTEPH
Start Date:
January 25, 2021
End Date:
October 30, 2022
Phase:
II
Institution:
Actelion
Study Summary
  • Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in subjects with inoperable or persistent/recurrent CTEPH.
Population:
CTEPH
Start Date:
July 7, 2020
End Date:
May 14, 2024
Phase:
3
Institution:
Actelion
Study Summary
  • The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).
Population:
PAH
Start Date:
November 20, 2019
End Date:
May 12, 2022
Phase:
I and II
Institution:
Laval University
Study Summary
  • The primary objective of this Phase 1B study is to confirm the safety of using olaparib in PAH patients, and precise the sample size of a future Phase 2 trial. In addition to safety, efficacy signals will thus be assessed.
Population:
Pediatric Pulmonary Hypertension (PPH)
Start Date:
October 2014
End Date:
December 2020
Phase:
Observational
Institution:
University of Colorado, Denver
Study Summary
  • The purpose of this study is to gather information about a large number of children with pulmonary hypertension over time, to increase understanding of the disease process and to lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.

Population:
PAH
Start Date:
September 28, 2017
End Date:
December 2023
Phase:
II
Institution:
Northern Therapeutics
Study Summary
  • The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic severe PAH on available PAH-targeted medical therapy.
Population:
PAH
Start Date:
February 14, 2020
End Date:
December 31, 2021
Phase:
Not Applicable
Institution:
V-Wave Ltd
Study Summary
  • The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

Population:
PAH
Start Date:
June 30, 2020
End Date:
October 31, 2023
Phase:
III
Institution:
Actelion
Study Summary
  • The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
Population:
PAH
Start Date:
July 29, 2019
End Date:
December 15, 2023
Phase:
III
Institution:
Actelion
Study Summary
  • This study aims to demonstrate that the FDC (fixed-dose combination) of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
Population:
Pediatric PAH
Start Date:
July 23, 2018
End Date:
February 11, 2026
Phase:
II
Institution:
Actelion
Study Summary
  • The aim of the present study is to confirm the doses of selexipag to be used in pediatric patients with PAH older than 2 years. To fulfill this aim, blood levels of selexipag (pharmacokinetic assessments) as well as the safety, and tolerability of selexipag in children with PAH will be assessed.
Population:
PAH
Start Date:
November 28, 2017
End Date:
July 14, 2022
Phase:
III
Institution:
Actelion
Study Summary
  • This is a prospective, multicenter, open-label, randomized, controlled, parallel group, group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and pharmacokinetics (PK) of macitentan in children.
     
Population:
PAH
Start Date:
August 30, 2018
End Date:
December 2022
Phase:
III
Institution:
United Therapeutics
Study Summary
  • Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Population:
PAH
Start Date:
June 1, 2019
End Date:
May 2021
Phase:
Observational
Institution:
Laval University
Study Summary
  • The investigators propose to determine whether or not MS seen in PAH patients impairs mitochondrial functions through an IRS1/PPARg/PGC1-dependent mechanism, which will ultimately decrease skeletal muscle function and perfusion, and thus overall exercise capacity.
Population:
Pediatric PAH
Start Date:
January 16, 2020
End Date:
December 9, 2024
Phase:
III
Institution:
Actelion
Study Summary
  • The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.
Population:
CTEPH
Start Date:
November 1, 2018
End Date:
November 2022
Phase:
Observational
Institution:
Queen's University
Study Summary
  •  Using new sophisticated technology, the investigators will determine the root causes of perceived breathing difficulty. The investigators will test the idea that breathlessness is fundamentally the result of increased drive to breathe from control centers in the brain. The investigators will measure drive to breathe by measuring the electrical activity descending from the brain to the main muscle of breathing - the diaphragm. 
Population:
PAH
Start Date:
April 26, 2016
End Date:
December 2020
Phase:
IV
Institution:
University of Calgary
Study Summary
  • This is a prospective, multi-center, open-label, exploratory study with patients followed for a period of one year. The treatment duration period in this study begins at the initiation of ambrisentan plus riociguat and will continue for 12 months. Patients will come to clinic for a visit at month 4 and 12. Assessments will include Right Heart Catheterization, 6 Minute walk test, cardiac MRI, questionnaires and nt-Pro-BNP.

Enrolling by Invitation

Population:
PAH
Start Date:
September 23, 2019
End Date:
September 2024
Phase:
III
Institution:
United Therapeutics
Study Summary
  • Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.
Population:
PAH
Start Date:
June 2021
End Date:
December 2021
Phase:
Not Applicable
Institution:
University of Calgary
Study Summary
  • This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension. The principal investigator and co-investigator will be unaware of allocation until after the beginning of the exercise program. There will be no blinding after intervention begins, as is typical with studies of exercise intervention.
Population:
PAH
Start Date:
March 2020
End Date:
March 2021
Phase:
Not Applicable
Institution:
Laval University
Study Summary
  • In this study, we intend to evaluate the impact of a 12 weeks home-based rehabilitation program on peripheral muscle function and metabolism, focusing on lipid infiltration, oxidative metabolism and epigenetic factors that can be involved in metabolic syndrome, in patients with Pulmonary Arterial Hypertension.
Population:
Sarcoidosis-associated Pulmonary Hypertension (SAPH)
Start Date:
January 15, 2021
End Date:
October 30, 2022
Phase:
II
Institution:
Actelion
Study Summary
  • Oral selexipag is commercially available in several countries for the treatment of a particular group of pulmonary hypertension (PH) called pulmonary arterial hypertension (PAH). The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).

Active (not recruiting)

Population:
PAH
Start Date:
May 2012
End Date:
August 2021
Phase:
III
Institution:
United Therapeutics
Study Summary
  • This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
Population:
Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (LEPHT)
Start Date:
April 14, 2010
End Date:
December 31, 2023
Phase:
II
Institution:
Bayer
Study Summary
  • The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction.
Population:
PAH
Start Date:
July 7, 2010
End Date:
April 2, 2021
Phase:
III
Institution:
Actelion
Study Summary
  • Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)
Population:
PAH
Start Date:
March 2016
End Date:
December 2022
Phase:
III
Institution:
Bellerophon Pulse Technologies
Study Summary
  • An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and PULSE-PAH-004 to provide these patients with continued access to chronic iNO until the time of approval or development of iNO in PAH is discontinued.
Population:
Pediatric Pulmonary Hypertension
Start Date:
August 2015
End Date:
December 2022
Phase:
Observational
Institution:
Association for Pediatric Pulmonary Hypertension
Study Summary
  • The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.